Chronic Back PainNCT07244237
Assessing Spinal Pain With an Artificial Intelligence-assisted Whole Body Electrical Stimulation Device
An observational study of Chronic Back Pain, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to investigate the correlation between self-reported pain and the measurements obtained using an artificial intelligence-assisted whole-body electrical stimulation device (StimaWELL 120MTRS system) in individuals with chronic back pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Back Pain
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2025to 15 Jan 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants will be recruited from the eligible and volunteer patients who will visit the healthy living center in study duration.
Who may be able to join
- Experiencing back pain for more than three months
- Experiencing recurrent back pain over the last week
- Not having used analgesic or muscle relaxant medications in the last week
- Aged between 18 and 60 years
- Diagnosed with chronic low back pain by a medical doctor
- Literate and able to cooperate with study procedures
- Willing to participate in the study
Who cannot join
- Having neurological, inflammatory, radiculopathy, vertebral fracture, or similar conditions
- Experiencing acute-onset pain
- Being pregnant or at risk of pregnancy
- Having a psychiatric diagnosis and currently taking medication
- Having a skin disease or lesion in the area where electrodes will be applied
- Currently undergoing physical therapy
Show all 12Show fewer
- Having vestibular, auditory, or cognitive impairments
- Possessing an electronic implant
- Having a cardiac arrhythmia
- Having a coronary or carotid stent
- Being diagnosed with epilepsy
- Having severe osteoporosis of the spine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity of an AI-Supported Whole-Body Electrical Stimulation Device for Spinal Pain Assessment: A Comparison With Self-Reported Pain Scores
The goal of this observational study is to investigate the correlation between self-reported pain and the measurements obtained using an artificial intelligence-assisted whole-body electrical stimulation device (StimaWELL 120MTRS system) in individuals with chronic back pain. The main question it aims to answer is: Is there any correlation between the pain intensity assessed with StimaWELL 120MTRS system, dolorimeter and self-report in adults with chronic back pain? The patients who have back pain for the duration longer than 3 months and have been eximaned by a medical doctor will be assessed with StimaWELL 120MTRS system, dolorimeter, and will be asked to rate their pain intensity in Numerical Pain Rating Scale.
Read the detailed description
The goal of this observational study is to investigate the correlation between self-reported pain and the measurements obtained using an artificial intelligence-assisted whole-body electrical stimulation device (StimaWELL 120MTRS system) in individuals with chronic back pain. This study is designed as an exploratory, cross-sectional study. After obtaining written and verbal informed consent, 200 patients with back pain will be asked about their age, sex, height, weight, and duration of back pain. Pain location and intensity will be assessed by one of the investigators using a body diagram and the Numerical Pain Rating Scale (NPRS). In addition, the patients will be evaluated by another investigator using the StimaWELL 120MTRS device, and using the dolorimeter for the pressure pain threshold (PPT). PPT will be assessed at four bilateral points: the upper trapezius, the lower trapezius, 5 cm lateral to the spinous process of the L3 vertebra, and 2 cm cranial to the posterior superior iliac spine. To achieve 80% power at a 5% significance level, assuming a medium effect size, estimated minimum sample size is calculated as 158 participants. Accordingly, the target sample size is set at 200 participants. Pearson's or Spearman's correlation coefficient will be used to determine the relationship between pain values measured by the artificial intelligence-assisted device and patient-reported pain scores (0-10) or pressure pain threshold. To assess the relationships among the three continuous variables obtained in this study-patient-reported pain scores (0-10), device-measured pain values, and pressure pain threshold-repeated-measures ANOVA or the Friedman test will be used to compare their means.
- Conditions
- Chronic Back Pain
- Keywords
- StimaWELL 120MTRS system, Chronic Back Pain, Measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic back pain | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured by the StimaWELL 120MTRS system
The StimaWELL® EMS device is a high-tech modulated low-frequency, 12-channel, mid-frequency stimulation device. The output of the calibration process will be recorded as data to use in the analysis.
Measured: baseline, one time
Pressure pain threshold
PPT will be assessed using a dolorimeter at four bilateral points (upper trapezius, lower trapezius, 5 cm lateral to L3 spinous process, and 2 cm cranial to the posterior superior iliac spine).
Measured: baseline, pre-procedure
Patient-reported pain
Participants will be asked to indicate the location of their back pain experienced over the last week on a body diagram, which shows the regions where the electrodes will be placed in a faint outline. For each marked region, participants will be asked to rate their pain intensity using the Numerical Pain Rating Scale. The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Higher scores represent greater pain intensity.
Measured: baseline, pre-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start15 Nov 2025
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Okuyucu, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244237
- Sponsor's protocol ID
- 14082025
- Status last verified
- May 2026
- First submitted
- 15 Aug 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will probably be shared on a reasonable request. But it is not decided yet.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of an AI-Supported Whole-Body Electrical Stimulation Device for Spinal Pain Assessment: A Comparison With Self-Reported Pain Scores
- ClinicalTrials.gov ID
- NCT07244237
- Acronym / sponsor ID
- 14082025
- Conditions
- Chronic Back Pain
- Keywords
- StimaWELL 120MTRS system, Chronic Back Pain, Measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to investigate the correlation between self-reported pain and the measurements obtained using an artificial intelligence-assisted whole-body electrical stimulation device (StimaWELL 120MTRS system) in individuals with chronic back pain. The main question it aims to answer is: Is there any correlation between the pain intensity assessed with StimaWELL 120MTRS system, dolorimeter and self-report in adults with chronic back pain? The patients who have back pain for the duration longer than 3 months and have been eximaned by a medical doctor will be assessed with StimaWELL 120MTRS system, dolorimeter, and will be asked to rate their pain intensity in Numerical Pain Rating Scale.
Detailed description
The goal of this observational study is to investigate the correlation between self-reported pain and the measurements obtained using an artificial intelligence-assisted whole-body electrical stimulation device (StimaWELL 120MTRS system) in individuals with chronic back pain. This study is designed as an exploratory, cross-sectional study. After obtaining written and verbal informed consent, 200 patients with back pain will be asked about their age, sex, height, weight, and duration of back pain. Pain location and intensity will be assessed by one of the investigators using a body diagram and the Numerical Pain Rating Scale (NPRS). In addition, the patients will be evaluated by another investigator using the StimaWELL 120MTRS device, and using the dolorimeter for the pressure pain threshold (PPT). PPT will be assessed at four bilateral points: the upper trapezius, the lower trapezius, 5 cm lateral to the spinous process of the L3 vertebra, and 2 cm cranial to the posterior superior iliac spine. To achieve 80% power at a 5% significance level, assuming a medium effect size, estimated minimum sample size is calculated as 158 participants. Accordingly, the target sample size is set at 200 participants. Pearson's or Spearman's correlation coefficient will be used to determine the relationship between pain values measured by the artificial intelligence-assisted device and patient-reported pain scores (0-10) or pressure pain threshold. To assess the relationships among the three continuous variables obtained in this study-patient-reported pain scores (0-10), device-measured pain values, and pressure pain threshold-repeated-measures ANOVA or the Friedman test will be used to compare their means.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic back pain | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants will be recruited from the eligible and volunteer patients who will visit the healthy living center in study duration.
Key inclusion criteria (7 listed)
- Experiencing back pain for more than three months
- Experiencing recurrent back pain over the last week
- Not having used analgesic or muscle relaxant medications in the last week
- Aged between 18 and 60 years
- Diagnosed with chronic low back pain by a medical doctor
Key exclusion criteria (12 listed)
- Having neurological, inflammatory, radiculopathy, vertebral fracture, or similar conditions
- Experiencing acute-onset pain
- Being pregnant or at risk of pregnancy
- Having a psychiatric diagnosis and currently taking medication
- Having a skin disease or lesion in the area where electrodes will be applied
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain intensity measured by the StimaWELL 120MTRS system
Time frame: baseline, one time
The StimaWELL® EMS device is a high-tech modulated low-frequency, 12-channel, mid-frequency stimulation device. The output of the calibration process will be recorded as data to use in the analysis.
Pressure pain threshold
Time frame: baseline, pre-procedure
PPT will be assessed using a dolorimeter at four bilateral points (upper trapezius, lower trapezius, 5 cm lateral to L3 spinous process, and 2 cm cranial to the posterior superior iliac spine).
Patient-reported pain
Time frame: baseline, pre-procedure
Participants will be asked to indicate the location of their back pain experienced over the last week on a body diagram, which shows the regions where the electrodes will be placed in a faint outline. For each marked region, participants will be asked to rate their pain intensity using the Numerical Pain Rating Scale. The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Higher scores represent greater pain intensity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Undecided. IPD will probably be shared on a reasonable request. But it is not decided yet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Back Pain, run by Amasya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity measured by the StimaWELL 120MTRS system (time frame: baseline, one time). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.